Oral Lichen PlanusNCT05997173
The Regulatory Role of Immune Response in Oral Lichen Planus
An observational study of Oral Lichen Planus, run by Peking University Third Hospital at 1 site in China.
Trial summary
Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Non erosive OLP and Erosive OLP
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with oral lichen planus or control Male or female patients older than 18 years of age Participants willing to participate with signed informed consent.
Who may be able to join
- patients with oral lichen planus
- male or female patients older than 18 years of age
- patients willing to participate with signed informed consent.
Who cannot join
- pregnant or lactating
- had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
- were unwilling to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
Lin Zeng contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Lin Zeng
01082266872
About this study
Official title: The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders
Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.
- Conditions
- Oral Lichen Planus
- Being tested
- Control, Non erosive OLP, Erosive OLP
- Keywords
- oral lichen planus, depression, anxiety, mesenchymal stem cells
- Medical subject headings
- Lichen Planus, Oral, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Investigation of scale of control
Non erosive OLPOther
Investigation of cale of non erosive OLP patients
Erosive OLPOther
Investigation of cale of erosive OLP patients
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal control group Receives: Other: Control | |
| Non erosive OLP | Non erosive oral lichen planus Receives: Other: Non erosive OLP | |
| Erosive OLP | Erosive oral lichen planus Receives: Other: Erosive OLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scores of the scale with the symptoms and signs of the disease
Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.
Measured: During the initial diagnosis，through study completion, an average of 1 year
Secondary outcomes (1)
Immune inflammatory response
Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.
Measured: During the initial diagnosis，through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start7 Sep 2020
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihui Zhang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997173
- Sponsor's protocol ID
- BMU81800920402
- Status last verified
- Sep 2022
- First submitted
- 15 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906.
PubMed 23901717Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
PubMed 27349424Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.
PubMed 22305766Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21.
PubMed 32871704Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29.
PubMed 30993798
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders
- ClinicalTrials.gov ID
- NCT05997173
- Acronym / sponsor ID
- BMU81800920402
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, depression, anxiety, mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: ControlNormal control group |
| Non erosive OLP | – | Other: Non erosive OLPNon erosive oral lichen planus |
| Erosive OLP | – | Other: Erosive OLPErosive oral lichen planus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with oral lichen planus or control Male or female patients older than 18 years of age Participants willing to participate with signed informed consent.
Key inclusion criteria (3 listed)
- patients with oral lichen planus
- male or female patients older than 18 years of age
- patients willing to participate with signed informed consent.
Key exclusion criteria (3 listed)
- pregnant or lactating
- had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
- were unwilling to participate in the experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlInvestigation of scale of control | Other | Control |
| Non erosive OLPInvestigation of cale of non erosive OLP patients | Other | Non erosive OLP |
| Erosive OLPInvestigation of cale of erosive OLP patients | Other | Erosive OLP |
Primary outcome
The scores of the scale with the symptoms and signs of the disease
Time frame: During the initial diagnosis，through study completion, an average of 1 year
Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.
1 secondary outcome
Immune inflammatory response
Time frame: During the initial diagnosis，through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 23901717Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906.
- Background: PubMed 27349424Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
- Background: PubMed 22305766Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.
- Background: PubMed 32871704Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21.
- Background: PubMed 30993798Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Zeng contact
Zhihui Zhang principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihui Zhang (010-82266125, wisdomzhangzhihui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scores of the scale with the symptoms and signs of the disease (time frame: During the initial diagnosis，through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997173, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.